Table 2.

Treatment-related adverse events (>10% of patients or grade ≥3) and laboratory abnormalities (hematological and biochemical) in patients with metastatic breast cancer treated with capecitabine plus lurbinectedin at all dose levels and at the recommended dose

	Capecitabine plus lurbinectedin
	RD (capecitabine 1650 mg/m2 D1-D14/lurbinectedin 2.2 mg/m2 D1) (n = 15)				All dose levels (n = 28)
NCI-CTCAE grade	1-2	3	4	Total	1-2	3	4	Total
Hematological laboratory abnormalities
Anemia	80	13	—	93	82	11	—	93
Neutropenia	27	40	7	73	25	32	25	82
Thrombocytopenia	73	—	—	73	64	7	—	71
Biochemical laboratory abnormalities
ALT increased	87	7	—	93	79	11	—	89
AP increased	47	—	—	47	54	—	—	54
AST increased	80	7	—	87	71	7	—	79
Bilirubin increased	40	—	—	40	29	—	—	29
CPK increased	20	—	—	20	21	—	—	21
Creatinine increased	93	—	—	93	96	—	—	96
Adverse events
Constipation	13	—	—	13	18	—	—	18
Decreased appetite	33	—	—	33	39	—	—	39
Diarrhea	33	—	—	33	46	—	—	46
Dyspepsia	33	—	—	33	43	—	—	43
Fatigue	40	7	—	47	50	7	—	57
Headache	7	—	—	7	11	—	—	11
Hypertriglyceridemia	—	—	—	—	—	4	—	4
Mucositis	33	—	—	33	32	—	—	32
Myalgia	13	—	—	13	7	—	—	7
Nausea	60	—	—	60	71	—	—	71
Palmar-plantar erythrodysesthesia syndrome	33	—	—	33	43	—	—	43
Paronychia	20	—	—	20	14	—	—	14
Peripheral sensory neuropathy	13	—	—	13	21	—	—	21
Pulmonary embolism	—	—	—	—	—	4	—	4
Vomiting	20	—	—	20	29	—	—	29
Weight decreased	13	—	—	13	7	—	—	7
Xerosis	—	—	—	—	11	—	—	11

Data shown are percentage of patients. Hematological and biochemical abnormalities are shown regardless of relationship to treatment.

ALT, alanine aminotransferase; AP, alkaline phosphatase; AST, aspartate aminotransferase; CPK, creatine phosphokinase; D, day; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; RD, recommended dose.